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Niacin for Obesity

Phase < 1
Recruiting
Led By Michael Jensen, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Males and females between 18 and 65 years of age who are able to comprehend instructions, follow study procedures, willing to sign an informed consent form, and consume an isoenergetic diet eating all meals from Mayo CRTU for at least 3 days prior to study
Upper body obesity criteria for men
Must not have
Persistent blood pressure greater than 160/95 despite antihypertensive medication
Concomitant use of medications that can alter free fatty acid metabolism
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approx. 6 hours
Awards & highlights
No Placebo-Only Group

Summary

This trial is studying why people who gain weight in their belly often don't respond to weight loss methods like those who are leaner.

Who is the study for?
This study is for men and women aged 18-65 who are overweight or obese, with a BMI of 29.0 - 40.0 kg/m2, especially those carrying extra weight around their abdomen. Participants must not have heart disease, high blood pressure that's uncontrolled by medication, be smokers, or take drugs affecting fat metabolism. They should also not be allergic to lidocaine or Niaspan.
What is being tested?
The trial is investigating how niacin affects fat tissue in people with different body types, particularly focusing on adults who carry excess abdominal weight and may react differently to factors that usually 'turn off' fat cells.
What are the potential side effects?
While the side effects of niacin are not detailed here, common ones include skin flushing or redness, itching or tingling sensations, digestive upset like nausea or indigestion, and increased blood sugar levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old, can follow instructions, and am willing to eat specific meals for 3 days before the study.
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I am a man with most of my body fat around my waist.
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My BMI is between 29.0 and 40.0.
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I am a woman with upper body or visceral obesity.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My blood pressure is still over 160/95 even with medication.
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I am taking medication that affects how my body uses fats.
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I am allergic to lidocaine, Niaspan, or indocyanine green.
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I have had heart disease related to narrowed arteries.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approx. 6 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and approx. 6 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in plasma free fatty acid (FFA) concentrations
Secondary study objectives
pHSL/HSL response

Side effects data

From 2008 Phase 4 trial • 30 Patients • NCT00203476
50%
Flushing
10%
Loose Stools
10%
Elevated LFTs
100%
80%
60%
40%
20%
0%
Study treatment Arm
Niacin
Colestipol
Ezetimibe

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Upper body obesityExperimental Treatment1 Intervention
Subjects identify with upper body obesity will receive Niacin to lean how fat cells in different regions of the body the response.
Group II: Normal weightExperimental Treatment1 Intervention
Subjects identify with normal body weight will receive Niacin to lean how fat cells in different regions of the body the response.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Niacin
2008
Completed Phase 4
~1010

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,333 Previous Clinical Trials
3,060,143 Total Patients Enrolled
88 Trials studying Obesity
9,137 Patients Enrolled for Obesity
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,443 Previous Clinical Trials
4,331,095 Total Patients Enrolled
469 Trials studying Obesity
589,705 Patients Enrolled for Obesity
Michael Jensen, MDPrincipal InvestigatorMayo Clinic
2 Previous Clinical Trials
72 Total Patients Enrolled
2 Trials studying Obesity
72 Patients Enrolled for Obesity
~21 spots leftby May 2027
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